Samawi H H, Brezden-Masley C, Afzal A R, Cheung W Y, Dolley A
Section of Hematology/Oncology, St. Michael's Hospital, Toronto, ON.
Section of Medical Oncology, Tom Baker Cancer Centre, Calgary, AB.
Curr Oncol. 2019 Oct;26(5):319-329. doi: 10.3747/co.26.5107. Epub 2019 Oct 1.
Outcomes for patients with metastatic colorectal cancer (mcrc) are improving with the introduction of new treatments. Treatment for patients who are still fit after failure of all available therapies represents a significant unmet need. In the present study, we analyzed real-world treatment patterns for patients enrolled in Health Canada's trifluridine/tipiracil (ftd/tpi) Special Access Program (sap) and Taiho Pharma Canada's Patient Support Program (psp).
Demographic information and clinical treatment data were collected from adults with mcrc who were previously treated with, or were not candidates for, available therapies and who were enrolled in the sap and psp. For all patients, ftd/tpi treatment status, discontinuation reasons, and prior therapies were examined.
The analysis included 717 Canadian patients enrolled in the ftd/tpi sap and psp from September 2017 to October 2018. In that cohort, 59.7% were men, median age was 65 years, and median duration of therapy was 77 days (25%-75% interquartile range: 43-106 days). Of treated patients, 67.1% maintained the same dose for the duration of therapy; 28.0% had a dose reduction.On multivariable analysis, duration of therapy was not influenced by sex, age, province, mutation status, or prior therapies. However, prior oxaliplatin-based chemotherapy (capox or folfox) appeared to be associated with higher rates of discontinuation because of death or disease progression.
In advanced mcrc, ftd/tpi is a well-tolerated therapy. The large number of patients enrolled in the access programs within a short period of time is reflective of major clinical need in this area, with many patients being eligible and interested in pursuing treatment in the refractory setting.
随着新治疗方法的引入，转移性结直肠癌（mCRC）患者的治疗结果正在改善。对于所有可用疗法均失败后仍身体状况良好的患者，治疗是一项重大的未满足需求。在本研究中，我们分析了参与加拿大卫生部三氟尿苷/替匹嘧啶（FTD/TPI）特殊准入计划（SAP）和日本大鹏制药加拿大患者支持计划（PSP）的患者的真实世界治疗模式。
收集患有mCRC的成年人的人口统计学信息和临床治疗数据，这些患者曾接受过可用疗法治疗或不适合可用疗法，且参与了SAP和PSP。对所有患者，检查FTD/TPI治疗状态、停药原因和既往治疗。
分析纳入了2017年9月至2018年10月参与FTD/TPI SAP和PSP的717例加拿大患者。在该队列中，59.7%为男性，中位年龄为65岁，中位治疗持续时间为77天（四分位间距25%-75%：43-106天）。在接受治疗的患者中，67.1%在治疗期间维持相同剂量；28.0%有剂量减少。多变量分析显示，治疗持续时间不受性别、年龄、省份、突变状态或既往治疗的影响。然而，既往基于奥沙利铂的化疗（ CapeOx或FOLFOX）似乎与因死亡或疾病进展导致的停药率较高相关。
在晚期mCRC中，FTD/TPI是一种耐受性良好的疗法。短时间内大量患者参与准入计划反映了该领域的主要临床需求，许多患者有资格并对难治性情况下的治疗感兴趣。
